Condition category
Infections and Infestations
Date applied
21/01/2016
Date assigned
11/03/2016
Last edited
11/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Bartonellosis, also known as Carrión's disease, is an infectious disease caused by the bacteria Bartonella bacilliformis. It is very common in the Andes mountain range, particularly in Peru, and is spread through the bites of sand flies. The infection usually takes part in two distinct phases. The first stage is known as Oroya fever, which is potentially life-threatening as red blood cells are destroyed so the body is unable to carry enough oxygen around the body (haemolytic anaemia). The second stage is the verrucous stage (verruga peruana, also known as the Peruvian wart) and involves long-term (chronic) skin lesions (wounds) on the limbs and face. They can last for months or even years, and are often accompanied by fever, tiredness and muscle pain. The infection mainly affects children, as their immune systems are still developing and they have not had time to become resistant through long-term exposure to the disease. One the verrucous stage clears up, most people are free from infection, however some people are still infected and can pass on the disease, even if they don’t have any symptoms. Two common drugs used to treat people in the verrucous stage are azithromycin and rifampin, however it is not known whether one is more effective than the other. The aim of this study is to find out whether azithromycin or rifampin is faster at clearing up Bartonellosis in the verrucous stage.

Who can participate?
Anyone who is showing signs of a long term Bartonellosis in the verrucous stage.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given rifampin treatment for two weeks, at a dose of 600mg tablets daily for participants over 8 years old and 10mg/kg daily of liquid medication for children under 8 years old. Those in the second group are treated with azithromycin a week for two weeks, at a dose of 1g for participants over 8 years old and 20mg/kg for children under 8 years old. Participants in both groups have blood samples taken at the start of the study and then again on day 7, 14, 40 and 60 in order to test the effectiveness of the medications. At these times, participants are also examined physically in order to see if their skin lesions have improved.

What are the possible benefits and risks of participating?
Participants could benefit from an improvement to their symptoms from the medications used in this study. There is a small risk of pain, bruising or infection from blood tests involved, as well as general side-effects associated with the medications used.

Where is the study run from?
Caraz Regional Hospital (Peru)

When is the study starting and how long is it expected to run for?
June 2003 to March 2004

Who is funding the study?
1. Uniformed Services University of the Health Sciences (USA)
2. Pfizer (USA)

Who is the main contact?
Dr David Blazes
david.blazes@usuhs.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Blazes

ORCID ID

Contact details

Dept of Tropical Public Health
Uniformed Services University of the Health Sciences
4301 Jones Bridge Road
Bethesda
20814
United States of America
+1 202 957 4446
david.blazes@usuhs.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G187OG-01

Study information

Scientific title

A randomized controlled treatment trial for the verrucous stage of Bartonella bacilliformis infection in Peru

Acronym

Study hypothesis

Thaim of this study is to determine the more efficacious drug for the treatment of the verrucous stage of Bartonella bacilliformis infection via a randomized, controlled trial, comparing azithromycin with rifampin.

Null Hypotheses:
1. There is no difference between azithromycin and rifampin treatment in the time to resolution of the verrucous rash of Bartonella bacilliformis infection
2. There is no difference between azithromycin and rifampin treatment in the duration of Bartonella bacilliformis bacteremia associated with the verrucous rash

Ethics approval

1. Naval Medical Research Center, 28/06/2001, ref: FWA-00000152
2. Services University of the Health Sciences, 12/04/2001, ref: FWA-00001628
3. Peruvian University Cayetano Heredia, 04/09/2001, ref: FWA-00000525

Study design

Community-based randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

No specific participant information sheet available, please use the contact details below to request a further information.

Condition

Bartonella bacilliformis infection

Intervention

Participants are randomly allocated to one of two groups using random computer generation of a scheme, blocked in groups of ten to ensure similar numbers will be assigned to each group.

Group 1: Adult participants receive Rifamin for two weeks at a dose of 600mg PO daily, Ch receild participants receive 10mg/kg daily (not to exceeding 600mg PO daily).

Group 2: Azithromycin .s administered once weekly for two weeks (which gives effective tissue levels for two weeks). Adults receive a 1.0 gram PO dose at Day 0 and Day 8 and children receive a 20mg/kg PO dose at Day 0 and Day 8 (not to exceed standard adult doses as above).

For both groups, liquid elixirs are provided for children less than eight years of age, with tablets for all patients older than eight years.

Participants in both groups are followed up after 7, 14, 30 and 60 days.

Intervention type

Drug

Phase

Phase III/IV

Drug names

1. Rifampin
2. Azithromycin

Primary outcome measures

1. Time to resolution of verrucous lesions is measured from photographs and physical examinations undertaken at baseline, 7, 14, 30 and 60 days
2. Time to resolution of Bartonella bacteremia is measured through blood culture and PCR undertaken at baseline, 7, 14, 30 and 60 days

Secondary outcome measures

1. Risk factors for Bartonella bacteremia measured using a questionnaire at baseline
2. Characteristics for clinical and laboratory findings associated with rash and Bartonella bacteremia measured at baseline, 7, 14, 30 and 60 days

Overall trial start date

16/06/2003

Overall trial end date

30/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 1 and 60 years
2. Clinical presentation compatible with Verruga peruana (chronic verrucous stage of Bartonellosis)
3. Able to provide informed consent/parental informed consent for children

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

127

Participant exclusion criteria

1. Pregnancy
2. Use of oral contraceptives
3. Breast-feeding
4. Admission to the hospital for an unrelated condition
5. Use of antibiotics within the month preceding potential enrollment in the trial
6. Chronic use of alcohol
7. Known chronic liver disease
8. Use of medications that potentially interact with rifampin or azithromycin during the study period

Recruitment start date

16/06/2003

Recruitment end date

15/12/2003

Locations

Countries of recruitment

Peru

Trial participating centre

Caraz Regional Hospital
9 de octubre Av S/N Caraz Huaylas
Ancash
-
Peru

Sponsor information

Organisation

Uniformed Services University of the Health Sciences

Sponsor details

4301 Jones Bridge Road
Bethesda
20814
United States of America
+1 301 295 3734
james.mancuso@usuhs.edu

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Uniformed Services University of the Health Sciences

Alternative name(s)

Uniformed Services University, USU of the Health Science, USUHS

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

Pfizer

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication of results papers in peer reviewed journals. The clinical trial data has also been presented at the ASTMH meeting in Philadelphia in November 2015.

Intention to publish date

01/06/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes